(228 days)
None
No
The summary describes a physical medical device (catheter) and its materials, intended use, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to drain urine from the bladder, which alleviates symptoms of chronic urine retention and voiding dysfunction, thus providing a therapeutic benefit.
No
The device is an intermittent catheter designed to drain urine from the bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical catheter made of polyurethane and MABS, with an integrated urine bag and hydrophilic coating. It is a hardware device for draining urine.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpeediCath Compact Set is a catheter used to drain urine directly from the bladder. It is a physical device inserted into the body for a therapeutic purpose (relieving urine retention), not for analyzing a sample outside the body.
- Intended Use: The intended use clearly states it's for draining urine due to voiding dysfunction, not for diagnostic testing of urine.
The information provided describes a medical device used for a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only.
Product codes
GBM
Device Description
The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing for SpeediCath Compact Set was conducted per applicable sections of voluntary and FDA consensus standards and the results were acceptable:
- Biocompatibility testing (cytotoxicity, irritation, sensitivity, and chemical characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)
- Coefficient of friction according to ASTM D1894:2014
- Corrosion according to EN ISO 20696:2018 and EN 1616 :1997
- Accelerated and Real Time aged shelf life testing according to ASTM F1980-16
- Sterilization dose setting according to ISO 11137-1:2015 and ISO/TS 13004:2013
The following tests were completed using established methods to determine the impact of the swelling medium modification based upon assessment of the risk documentation and the results were acceptable:
- Catheter coating - finger test
- Catheter coating dry out in air
- Catheters, objective friction measurement
- pH of the swelling medium
- Osmolality of the swelling medium
The performance testing demonstrates the subject device is as safe and as effective as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
SpeediCath Compact Set, K121458
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 13, 2020
Coloplast Michael Bumgarner Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K200820
Trade/Device Name: SpeediCath Compact Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: October 2, 2020 Received: October 5, 2020
Dear Michael Bumgarner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SpeediCath Compact Set
Indications for Use (Describe)
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
SpeediCath Compact Set Traditional 510(k)
Image /page/3/Picture/1 description: The image shows the Coloplast logo with the text "K200820 Page 1 of 3" in the upper right corner. The logo consists of a blue globe-like symbol with horizontal lines and the word "Coloplast" in blue, bold letters. The text indicates that this is page 1 of a 3-page document with the identification number K200820. The overall impression is that this is a document from Coloplast, possibly related to a product or service.
510(K) SUMMARY 5.0
| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Michael Bumgarner
Principal Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis, MN 55411
612-263-0488
usmbum@coloplast.com |
| Date of Summary: | 13 November 2020 |
| Trade or Proprietary
Name: | SpeediCath Compact Set |
| Common or Usual Name: | Catheter, Urethral |
| Classification Name: | Urological Catheter and Accessories |
| Regulation Number | 21 CFR 876.5130 |
| Classification: | Class II |
| Product Code: | GBM (Catheter, urethral) |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Compact Set, K121458
The predicate device has not been subject to a design related recall. |
4
SpeediCath Compact Set
Traditional 510(k)
Device Description: The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter. SpeediCath Compact Set is indicated for use by patients with Indications for Use: chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only. The subject and predicate devices have the same intended use. Comparison of Technical The subject device and predicated device have different technological characteristics as follows: Characteristics: -Swelling medium in the subject contains polyethylene glycol (PEG); the predicate contains polyvinylpyrrolidone (PVP). The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.
5
Traditional 510(k)
Image /page/5/Picture/2 description: The image shows the Coloplast logo in blue. The text "K200820 Page 3 of 3" is located in the upper right corner of the image. The logo is a sphere with horizontal lines and the word "Coloplast" next to it.
Summary of Non-Clinical Performance Testing:
Performance testing for SpeediCath Compact Set was conducted per applicable sections of voluntary and FDA consensus standards and the results were acceptable:
- . Biocompatibility testing (cytotoxicity, irritation, sensitivity, and chemical characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)
- Coefficient of friction according to ASTM D1894:2014 ●
- Corrosion according to EN ISO 20696:2018 and EN 1616 :1997
- . Accelerated and Real Time aged shelf life testing according to ASTM F1980-16
- Sterilization dose setting according to ISO 11137-1:2015 and ISO/TS 13004:2013
The following tests were completed using established methods to determine the impact of the swelling medium modification based upon assessment of the risk documentation and the results were acceptable:
- Catheter coating - finger test
- Catheter coating dry out in air ●
- Catheters, objective friction measurement
- pH of the swelling medium
- Osmolality of the swelling medium
Conclusion: The performance testing demonstrates the subject device is as safe and as effective as the predicate device.